Methods for programming a deep brain stimulation system and a clinician programmer device

ABSTRACT

In some embodiments, a clinician programmer device for controlling a deep brain stimulation (DBS) system is adapted to assist a clinician to conduct an electrode screening review for the DBS system including screening of segmented electrodes. The clinician programmer stores software code for conducting a screening review in memory. The software code may comprise: code for providing one or more interface screens for guiding the user of the device through testing of electrode configurations of the implantable stimulation lead, wherein the code for providing applies at least one testing progression for guiding the user of the device through a defined testing order.

TECHNICAL FIELD

This application is generally related to methods for programming a deepbrain stimulation system and a clinician programmer device.

BACKGROUND INFORMATION

Deep brain stimulation (DBS) refers to the delivery of electrical pulsesinto one or several specific sites within the brain of a patient totreat various neurological disorders. For example, deep brainstimulation has been proposed as a clinical technique for treatment ofchronic pain, essential tremor, Parkinson's disease (PD), dystonia,epilepsy, depression, obsessive-compulsive disorder, and otherdisorders.

A deep brain stimulation procedure typically involves first obtainingpreoperative images of the patient's brain (e.g., using computertomography (CT) or magnetic resonance imaging (MRI)). Using thepreoperative images, the neurosurgeon can select a target region withinthe brain, an entry point on the patient's skull, and a desiredtrajectory between the entry point and the target region. In theoperating room, the patient is immobilized and the patient's actualphysical position is registered with a computer-controlled navigationsystem. The physician marks the entry point on the patient's skull anddrills a burr hole at that location. Stereotactic instrumentation andtrajectory guide devices are employed to control the trajectory andpositioning of a lead during the surgical procedure in coordination withthe navigation system.

Brain anatomy typically requires precise targeting of tissue forstimulation by deep brain stimulation systems. For example, deep brainstimulation for Parkinson's disease commonly targets tissue within orclose to the subthalamic nucleus (STN). The STN is a relatively smallstructure with diverse functions. Stimulation of undesired portions ofthe STN or immediately surrounding tissue can result in undesired sideeffects. For example, muscle contraction or muscle tightening may becaused by stimulation of neural tissue that is near the STN. Mood andbehavior dysregulation and other psychiatric effects have been reportedfrom undesired stimulation of neural tissue near the STN in Parkinson'spatients.

To avoid undesired side effects in deep brain stimulation, neurologistsoften attempt to identify a particular electrode for stimulation thatonly stimulates the neural tissue associated with the symptoms of theunderlying disorder while avoiding use of electrodes that stimulateother tissue. Also, neurologists may attempt to control the pulseamplitude, pulse width, and pulse frequency to limit the stimulationfield to the desired tissue while avoiding other tissue.

As an improvement over conventional deep brain stimulation leads, leadswith segmented electrodes have been proposed. Conventional deep brainstimulation leads include electrodes that fully circumscribe the leadbody. Leads with segmented electrodes include electrodes on the leadbody that only span a limited angular range of the lead body. The term“segmented electrode” is distinguishable from the term “ring electrode.”As used herein, the term “segmented electrode” refers to an electrode ofa group of electrodes that are positioned at approximately the samelongitudinal location along the longitudinal axis of a lead and that areangularly positioned about the longitudinal axis so they do not overlapand are electrically isolated from one another. For example, at a givenposition longitudinally along the lead body, three electrodes can beprovided with each electrode covering respective segments of less than120 degrees about the outer diameter of the lead body. By selectingbetween such electrodes, the electrical field generated by stimulationpulses can be more precisely controlled and, hence, stimulation ofundesired tissue can be more easily avoided.

An example of a deep brain stimulation lead is the INFINITY™ directionallead manufactured by Abbott (Plano, Tex.). The INFINITY™ directionallead includes two conventional electrodes and two sets of segmentedelectrodes. The two sets of segmented electrodes are positioned inbetween the two conventional electrodes. Each set of segmentedelectrodes includes three segmented electrodes distributed about thecircumference of the lead at a given axial position. The INFINITY™ deepbrain stimulation system includes a clinician programmer that permitsthe neurologist or other clinician to program the DBS implantable pulsegenerator to deliver electrical pulses through the various electrodes ofthe INFINITY™ directional leads.

Although DBS stimulation leads with segmented electrodes provide anopportunity to tailor the stimulation therapy in a manner that is notpossible with conventional leads, programming DBS systems that includesegmented electrodes may be challenging for neurologists and otherhealth care professionals. Specifically, clinicians responsible forprogramming DBS systems are allocated a limited amount of time to selectDBS program parameters for a patient's DBS therapy. The increased numberof active electrode possibilities in combination with other DBSparameters increases the complexity of determining an optimal DBStherapy for a given patient.

SUMMARY

In some embodiments, a clinician programmer device is adapted orconfigured to control a deep brain stimulation (DBS) system. Theclinician programmer comprises: a display; user input circuitry forreceiving input from a user of the device; memory for storing executableinstructions and data; a processor for controlling operations of theclinician programmer according to executable instructions; and wirelesscommunication circuitry for conducting wireless communications with animplantable pulse generator after implantation within a patient. Thememory of the clinician programmer stores software code for conducting ascreening review of electrodes of an implantable stimulation leadcoupled to the implantable pulse generator, wherein the electrodes ofthe implantable stimulation lead include at least one set of segmentedelectrodes.

In some embodiments, the software code comprises: (a) code for providingone or more interface screens for guiding the user of the device throughtesting of electrode configurations of the implantable stimulation lead,wherein the code for providing applies at least one testing progressionfor guiding the user of the device through a defined testing order,wherein the at least one testing progression includes (i) testing allsegmented electrodes of a common level as active DBS electrodes and (ii)testing each segmented electrode of the common level as a single activeDBS electrode; (b) code for controlling delivery of deep brainstimulation to the patient by communication with the implantable pulsegenerator for each tested electrode configuration, wherein the code forcontrolling modifies a DBS pulse amplitude for each tested electrodeconfiguration; and (c) code for receiving identification of atherapeutic window for one or more DBS parameters for each testedelectrode configuration, wherein the therapeutic window is defined byone or more DBS parameters used for test stimulation for a DBS benefitand a DBS side effect experienced by the patient during testing. In someembodiments, the code for receiving identification records a side effectamplitude value in response receiving input from the user of the deviceto indicate that the user has experienced a side effect and the code forcontrolling automatically decreases the DBS pulse amplitude to anamplitude value below the recorded amplitude value. In some embodiments,the code for controlling automatically decreases the DBS pulse amplitudewithout substantially interrupting deep brain stimulation of the patientaccording to an electrode configuration under test.

In some embodiments, the software code further comprises: code forcomparing therapeutic windows for each tested electrode configuration toa target value and code for alerting a user of the device that thetarget value has been reached. In some embodiments, the code foralerting receives input from the user of the device whether to skipadditional electrode screening after the target value has been reached.In some embodiments, the software code further comprising: code forcomparing power requirements associated with the therapy thresholds forthe tested electrode configuration to inform the user of the devicewhether each electrode configuration is likely to provide an optimal DBSprogram for the patient. In some embodiments, the software code furthercomprises: code for suggesting omission of testing of one or moreelectrode configurations based on screening review data previouslyrecorded for the patient by the code of receiving identification.

In some embodiments, the software code comprises: (a) code for providingone or more interface screens for guiding the user of the device throughtesting of electrode configurations of the implantable stimulation lead,wherein the code for providing applies different progressions forelectrode testing depending upon an identification of an electrode orelectrode level to begin a screening review session; (b) code forcontrolling delivery of deep brain stimulation to the patient bycommunication with the implantable pulse generator for each testedelectrode configuration, wherein the code for controlling modifies a DBSpulse amplitude for each tested electrode configuration; and (c) codefor receiving identification of a therapeutic window for one or more DBSparameters for each tested electrode configuration, wherein thetherapeutic window is defined by one or more DBS parameters used fortest stimulation for a DBS benefit and a DBS side effect experienced bythe patient during testing.

In some embodiments, the code for providing evaluates therapeutic windowparameters for a first set of segmented electrodes and a second set ofelectrodes. In some embodiments, the code for providing omits screeningof one ring electrode depending upon a comparison of the therapeuticwindow parameters for the first and second sets of segmented electrodes.In some embodiments, the code for providing changes an order of testingindividual segmented electrodes depending upon a comparison of thetherapeutic window parameters for the first and second sets of segmentedelectrodes.

In some embodiments, the software code comprises: (a) code for providingone or more interface screens for guiding the user of the device throughtesting of electrode configurations of the implantable stimulation lead,wherein the code for providing applies at least a first progression anda second progression for electrode testing in series, and wherein thesecond progression is selected from at least two options according topatient response data obtained during the first progression; (b) codefor controlling delivery of deep brain stimulation to the patient bycommunication with the implantable pulse generator for each testedelectrode configuration, wherein the code for controlling modifies a DBSpulse amplitude for each tested electrode configuration; and (c) codefor receiving identification of a therapeutic window for one or more DBSparameters for each tested electrode configuration, wherein thetherapeutic window is defined by one or more DBS parameters used fortest stimulation for a DBS benefit and a DBS side effect experienced bythe patient during testing.

In some embodiments, the code for providing evaluates therapeutic windowparameters for a first set of segmented electrodes and a second set ofelectrodes. In some embodiments, the code for providing selects anoption from the at least two options by comparing the therapeutic windowparameters for a first set of segmented electrodes and a second set ofelectrodes. The at least two options may define different sets ofsegmented electrodes for screening.

In some embodiments, the software code comprises: (a) code for providingone or more interface screens for guiding the user of the device throughtesting of electrode configurations of the implantable stimulation lead;(b) code for controlling delivery of deep brain stimulation to thepatient by communication with the implantable pulse generator for eachtested electrode configuration, wherein the code for controllingmodifies a DBS pulse amplitude for each tested electrode configuration;and (c) code for receiving identification of a therapeutic window forone or more DBS parameters for each tested electrode configuration,wherein the therapeutic window is defined by one or more DBS parametersused for test stimulation for a DBS benefit and a DBS side effectexperienced by the patient during testing, wherein the code forcontrolling automatically reduces a DBS pulse amplitude in response tothe user of the device providing input to the code for receiving toidentify a side effect experienced by the patient.

In some embodiments, the code for providing evaluates therapeutic windowparameters for a first set of segmented electrodes and a second set ofelectrodes. In some embodiments, the code for providing omits screeningof one ring electrode depending upon a comparison of the therapeuticwindow parameters for the first and second sets of segmented electrodes.In some embodiments, the code for providing changes an order of testingindividual segmented electrodes depending upon a comparison of thetherapeutic window parameters for the first and second sets of segmentedelectrodes.

The foregoing and other aspects, features, details, utilities andadvantages of the present disclosure will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a tip of a deep brain stimulation lead that may beemployed according to some embodiments.

FIG. 2 depicts a system for deep brain stimulation according to someembodiments.

FIG. 3 depicts a user interface screen for conducting a screening reviewof electrodes for a DBS therapy for a patient according to someembodiments.

FIG. 4 depicts a GUI dialog for entry of patient response data accordingto some embodiments.

FIG. 5 depicts a GUI dialog for entry of patient response data accordingto some embodiments.

FIGS. 6 and 7 depict graphical representations of patient response dataaccording to some embodiments.

FIGS. 8-15 depict flowcharts of operations for conducting a screeningreview of electrodes for a DBS therapy for a patient according to someembodiments.

FIG. 16 depicts a clinician programmer device according to someembodiments.

FIG. 17 depicts a flowchart for treating a neurological disorder of apatient using an implantable pulse generator and a lead with segmentedelectrodes according to some embodiments.

DETAILED DESCRIPTION

The present application is generally related to systems and methods forproviding deep brain stimulation (DBS) therapy to a patient using a DBSsystem that includes one or more directional leads. In some embodiments,a clinician programmer device includes clinician software that permits aneurologist or other health care clinician to evaluate a patient'sresponse to deep brain stimulation applied through various conventionalring and segmented electrodes of directional lead. The clinicianprogrammer guides the health care professional through electrodes andelectrode combinations in an efficient manner while permitting theclinician to monitor beneficial therapeutic results and avoiding adverseor unwanted side effects. The review of the patient response using thevarious electrodes and electrode combinations enables the clinician toarrive at an optimal DBS program to treat the patient's neurologicaldisorder.

FIG. 1 depicts a distal portion of deep brain stimulation lead 100 thatmay be used according to some embodiments. DBS lead 100 includes twosets of segmented electrodes 101 that are located in between twoconventional electrodes 102 (referred to as a 1-3-3-1 configuration).Stimulation lead 100 may include a radio-opaque feature or other imagingfeature 112 that permits the orientation of lead 100 to be determinedafter it is implanted at a suitable DBS location. The various electrodesare connected to hypotubes 125 which are embedded in molded polymermaterial. The fabrication of DBS lead 100 may occur using suitableimplantable device fabrication processes such as the processes describedin U.S. Patent App. Pub. No. 20160263370, entitled “MEDICAL LEADS WITHSEGMENTED ELECTRODES AND METHODS OF FABRICATION THEREOF,” which isincorporated herein by reference. The INFINITY™ directional leadmanufactured by Abbott (Plano, Tex.) may be used according to someembodiments. Although one specific configuration is shown in FIG. 1, anysuitable configuration of electrodes and any suitable directional leadmay be employed according to some embodiments.

FIG. 2 depicts neurostimulation system 200 according to someembodiments. Neurostimulation system 200 includes pulse generator 220and one or more directional leads 100. Examples of pulse generatorsinclude the BRIO™ and INFINITY™ pulse generators manufactured by Abbott(Plano, Tex.). Pulse generator 220 is typically implemented using ametallic housing that encloses circuitry for generating the electricalpulses for application to neural tissue of the patient. Controlcircuitry, communication circuitry, and a non-rechargeable or arechargeable battery (not shown) are also typically included withinpulse generator 220. Pulse generator 220 is usually implanted within asubcutaneous pocket created under the skin by a physician.

Lead 100 is electrically coupled to the circuitry within pulse generator220 using header 210. Lead 100 includes terminals (not shown) that areadapted to electrically connect with electrical connectors (e.g.,“Bal-Seal” connectors which are commercially available and widely known)disposed within header 210. The terminals are electrically coupled toconductors (not shown) within the lead body of lead 100. The conductorsconduct pulses from the proximal end to the distal end of lead 100. Theconductors are also electrically coupled to electrodes 101 and 102 toapply the pulses to tissue of the patient.

The use of segmented electrodes 101 in system 200 permits the clinicianto more precisely control the electrical field generated by thestimulation pulses and, hence, to more precisely control the stimulationeffect in surrounding tissue. One or more of electrodes 101 and 102 maybe additionally or alternatively utilized to sense electrical activityat the implant location for some embodiments where generator 220includes suitable sensing circuitry.

Pulse generator 220 preferably wirelessly communicates with programmerdevice 250. Programmer device 250 enables a clinician to control thepulse generating operations of pulse generator 220. The clinician canselect electrode combinations, pulse amplitude, pulse width, frequencyparameters, and/or the like using the user interface of programmerdevice 250. The parameters can be defined in terms of “stim sets,”“stimulation programs,” (which are known in the art) or any othersuitable format. As used herein, a “stimulation program” refers to oneor more sets of stimulation parameters that permit a pulse generator toprovide a neurostimulation therapy to a patient. Programmer device 250responds by communicating the parameters to pulse generator 220 andpulse generator 220 modifies its operations to generate stimulationpulses according to the communicated parameters. Any suitable wirelesscommunication method may be used for communications between programmerdevice 250 and pulse generator 220 such as near field inductivecommunication and any suitable various far field communication method.For example, the INFINITY™ deep brain stimulation system of Abbott usesBLUETOOTH™ low energy for communication with an implanted pulsegenerator. Programmer device 250 includes various hardware componentssuch as a display (e.g., a touch screen), one or more user inputbuttons, battery, processor, memory, wireless communication circuitry,interface components, etc. Commercially available devices may beemployed for the hardware components of programmer device 250 such asAPPLE IOS IPAD™ devices.

Programmer device 250 includes software (one or more “apps”) thatprovides one or more user interface screens to permit a clinician toidentify one or more suitable or optimal deep brain stimulation programsfor a given patient and to program pulse generator 220 according to theidentified program(s).

FIG. 3 depicts a user interface screen 300 that includes variousgraphical user interface components for conducting a monopolar review. Amonopolar review refers to a programming session in which deep brainstimulation is applied to a patient using various electrode combinationsand stimulation parameters. The review is “monopolar” because eachactive electrode of the stimulation lead has a negative polarity duringapplication of stimulation pulses and the pulse generator case is usedas the return electrode (positive polarity). Although monopolar reviewis described for some embodiments, other embodiments may employmultipolar electrode configurations.

UI screen 300 permits the clinician to apply electrical stimulation atdifferent amplitudes for the various electrode and electrodecombinations to identify amplitudes for relevant patient responses. Forexample, the clinician may determine for each electrode or electrodecombination the amplitude value that causes an expected complete benefitfor the stimulation therapy (such as elimination of tremor). Also, theclinician may likewise determine the value that causes a sustained sideeffect (e.g., tingling, tightening, mood changes, or flashing). After anappropriate number of electrodes or combinations have been tested, theclinician may review the recorded data on programming device 250 orelsewhere to select or create an optimal DBS program for the patient.The optimal DBS program may commonly include identification of one ormore active electrodes, pulse frequency, pulse width, and pulseamplitude parameters.

UI screen 300 provides an efficient workflow progression for themonopolar review. The clinician may test through a progression ofelectrodes and/or electrode combinations without necessarily leaving thesingle screen. Also, UI screen 300 permits the automatic capture of therelevant data without leaving the single screen. The arrangement of GUIcomponents with interrelated functionality permits the relativelycomplex task of completing a monopolar review to occur with a minimalburden on the clinician.

UI screen 300 includes icon 320 that may be used to start a monopolarreview session. The clinician may tap icon 320. If the clinician selectsto start a monopolar review session, the current program (if valid) issaved and the monopolar workflow process begins in which the clinicianmay progress through the various electrodes and electrode combinations.The clinician may select the respective stimulation lead for themonopolar review (e.g., select between the leads implanted on the rightand left hemispheres of the patient).

UI screen 300 includes electrode progression navigation GUI component301. GUI component 301 provides a series of electrode selections for themonopolar review. Clinician programmer device 250 automatically guidesthe clinician through screening of the electrodes/combinations accordingto the electrodes shown in GUI component 301. When screening of a givenelectrode or combination is completed, the clinician may proceed to thenext defined electrode or combination by selecting the “next” arrow inGUI component 301. After the clinician selects the “next” arrow,clinician programmer device 250 automatically changes the activeelectrodes by communicating with the implantable pulse generator 220 ofthe patient.

If the clinician wishes to depart from the defined order, the clinicianmay select other GUI components associated with a specific electrode orelectrode combination. For example, the clinician may select one of theelectrodes in the depiction of the directional lead to screen theselected electrode. Also, GUI component 301 includes radio buttonelements that permit the clinician to provide test stimulation for aspecific electrode and/or electrode combination. In FIG. 3, GUIcomponent 301 includes radio button elements 1-4. In option 1, the ringelectrode 1 (the most distal electrode) is active for the teststimulation. In option 2 ABC, all segmented electrodes on the secondmost distal level are active for the test stimulation. In option 3 ABC,all segmented electrodes on the third most distal level are active forthe test stimulation. In options 2 ABC and 3 ABC, the individualsegmented electrodes at each level are identified as segmentedelectrodes A, B. and C respectively. When all of the segmentedelectrodes are active at a given level, the stimulation field isgenerally extended in a 360 degree manner about the lead. In option 4,the most proximal ring electrode is active for the test stimulation. Onespecific electrode progression in shown in FIG. 3. Other electrodeprogressions for screening are described herein. A given electrodeprogression need not include all possible electrode options. Forexample, when the clinician finishes screening of a first electrodeprogression of several electrodes/combinations, UI screen 300 maypresent a second electrode progression. The specific order or contentsof the second electrode progression may depend upon the patient responsedata obtained during screening of the first electrode progressionaccording to some embodiments.

GUI component 301 includes additional options for individual segmentedelectrodes which are shown as options 2 A, 2 B, 2 C, 3 A, 3 B, and 3 C.For each of these options, the identified segmented electrode (eitherelectrode A, B, or C) on levels 2 or 3 are active.

In some embodiments, the clinician may select a specific electrode orelectrode combination deemed more likely to result in an optimal DBSprogram. For example, the clinician may believe that a specificelectrode is more likely located in an optimal location for deep brainstimulation. This may be based on imaging and/or intraoperativemicroelectrode recording (MER) data or any other suitable clinicalinformation. If the clinician decides to begin with a specific electrodeor combination, the clinician may provide input corresponding to thedesired electrode or electrode combination.

As the clinician completes screening for a given electrode or electrodecombination, GUI component 301 may be updated to reflect the completionstatus for the electrode or electrode combination (e.g., the color ofthe corresponding radio button is changed). If the clinician does notintentionally modify the screening order, programming device 250 willautomatically proceed through the screening according to the orderspecified by the defined electrode progression (in response to theclinician selecting the “next” GUI element of GUI component 301).

User interface screen 300 includes GUI components 302-305 to control thetest stimulation applied during analysis of the patient response tostimulation by a given electrode or electrode combination. GUIcomponents 304 and 305 permit the clinician to control the pulse widthand pulse frequency for the deep brain stimulation. GUI components 304and 305 may allow the clinician to enter the desired values via textentry, through selection from a set of values, or any other suitableentry method. These DBS parameters are generally not varied acrossdifferent electrodes during a monopolar review although there isoccasionally some variation in these parameters among differentpatients. The pulse amplitude and the electrode configuration are theDBS parameters that are commonly analyzed during a monopolar reviewsession to arrive at an optimal DBS therapy.

When the clinician begins a screening session or when the cliniciantransitions to the next electrode or electrode combination, programmerdevice 250 communicates with implantable pulse generator 220 to set theelectrodes to the appropriate states (e.g., communicates the definedelectrode configuration). The electrode or electrodes in the electrodecombination are set to active and all other electrodes of the lead areset to neutral for a monopolar review. The case of the IPG is used asthe return electrode. As used herein, an electrode configuration refersto the set of electrode states for an electrode combination under test.The electrode configuration may include one active electrode or multipleactive electrodes. Also, the initial amplitude is set to zero or asuitable minimum amount. The clinician may select an amplitude step sizein GUI component 303. As shown in FIG. 3, constant current pulses areapplied and hence the pulse amplitude is given in milliamperes. Voltagepulses may be employed for other embodiments and the pulse amplitude insuch cases is a voltage value. The clinician may turn stimulation on byan initial selection of button 306. When stimulation is turned on for agiven electrode or electrode combination, the amplitude begins at zeroor a suitable minimum value. The clinician may then increase or decreasethe pulse amplitude using buttons 306 and 307 of GUI component 303respectively. The amplitude is increased or decreased according to theamplitude step size for each touch or other selection of buttons 306 and307. As the clinician modifies the amplitude, the clinician observes orotherwise monitors the patient response and provides additional input toUI screen 300 to record or document the patient response.

When the clinician modifies the pulse amplitude via buttons 306 and 307,programmer device 250 communicates a suitable signal to the pulsegenerator 220 to modify the pulse amplitude. Pulse generator 220 appliesstimulation according to the current deep brain stimulation parameters(pulse frequency, pulse width, and pulse amplitude) displayed in UIinterface 300 via the current electrode or electrode combination. Duringthe analysis of a given electrode or electrode combination, pulsegenerator 220 continuously or substantially continuously appliesstimulation while the amplitude is gradually increased according to theselected step size. As used herein, substantially continuous stimulation(or equivalently stimulation without substantial interruption) meansstimulation without interruption for one second or more.

As the clinician increases amplitude, the patient response will likelychange. The clinician may use UI screen 300 to record when a specificpatient response occurs at an identified pulse amplitude. The clinicianmay indicate when the patient experiences an initial beneficialtherapeutic response (e.g., a beneficial change in a respective movementdisorder symptom). For example, the patient may more easily perform abodily movement or the patient's tremor is reduced or eliminated. Theclinician may indicate the amplitude at which a partial beneficialresponse occurs. Also, the clinician may indicate the pulse amplitude atwhich a complete benefit for a given neurological symptom occurs. Theclinician may indicate at which amplitude a transient side effect isexperienced and may indicate at which amplitude a sustained side effectis experienced. Depending upon the neurological disorder and/orclinician preferences, multiple types of benefits may be defined andmultiple side effects may be defined for identification via UI screen300.

The recording of the relevant amplitudes for benefits and side effectsmay occur by touch of buttons 308 and 309 respectively. When theclinician selects one of buttons 308 and 309, a pop over dialogcomponent may be displayed to capture additional information. FIG. 4depicts dialog component 400 for capturing benefit information. FIG. 5depicts dialog component 500 for capturing side effect information. Theclinician may enter text notations to provide additional informationrelated to a given amplitude value for a benefit or side effect ifdeemed appropriate by the clinician.

When the clinician identifies a relevant amplitude using these buttons,the amplitude is stored with a suitable identification (partial benefit,complete benefit, transient side effect, or sustained side effect). Theamplitude values are stored for subsequent review by the clinician tofacilitate identification an optimal DBS program.

UI screen 300 modifies its display as the amplitude values for relevantbenefits and side effects are identified by the clinician. Therespective identified amplitudes are displayed using markers 311 shownabove the amplitude control component 310. UI screen 300 includes graph312 that depicts the various amplitudes for one or more electrodes. Fora ring electrode as shown in FIG. 3, the identified amplitudes are shownas concentric rings with diameters defined by the respective amplitudevalues. For segmented electrodes, the identified amplitudes may be shownas points at distances defined by the respective amplitude values andpositioned proximate to each corresponding segmented electrode. Graph312 for the segmented levels may connect the corresponding amplitudesfor each segmented electrode with lines or suitable curves. For example,lines may connect the amplitude values for the compete benefit pointsfor each adjacent segmented electrode.

In some embodiments, programmer device 250 automatically performs one ormore operations when the clinician identifies a side effect by tappingor touching button 309. Programmer device 250 records the current pulseamplitude as the identified amplitude for the side effect. To avoidcontinuous stimulation of the patient at a level causing a sustainedside effect, programmer device 250 automatically decreases the pulseamplitude by the step size by selection of button 309 according to someembodiments. Programmer device 250 communicates a suitable messagethrough its wireless communication circuitry to pulse generator 220 tomodify the pulse amplitude of the current DBS program. The stimulationcontinues without substantial interruption but at an amplitude justbelow the level at which the side effect was experienced. In someembodiments, programmer device 250 modifies amplitude control component310 to include a green portion up to the current amplitude value (afterthe automatic downward adjustment) and to include a dark grey portionfrom the end of the green portion up to the amplitude at which the sideeffect was experienced by the patient. By performing these operationsautomatically, the amount of discomfort experienced by the patient isminimized without requiring additional actions by the clinician andwithout compromising the integrity of the recorded data.

As previously noted, the clinician may perform an analysis for eachelectrode or electrode combination in the order listed in UI screen 300.As the clinician analyzes the patient response for a specific electrodeand electrode combination, programmer device 250 may suggest that nofurther testing is likely to lead to a substantially better DBS programbased on the data collected at that point. Also, programmer device 250may suggest progression to a specific electrode or electrode combinationor may suggest skipping a specific electrode or electrode combinationbased on the data collected at that point. Programmer device 250 mayprovide different electrode progressions at certain transition pointsdepending upon the collected patient response data.

When the clinician completes testing of relevant electrodes andelectrode combinations or at any suitable time, the clinician may viewautomatically generated reports for the completed monopolar review data.FIG. 6 depicts report 600 that includes graphical components for themonopolar review data. Graph 601 represents the data from the analysisof stimulation applied to ring electrode of contact 1. Graph 601 depictsrespective concentric circles which include a representation 611 of theamplitude level at which a complete benefit was identified and arepresentation 612 of the amplitude level at which a sustained sideeffected was identified. Graph 602 is similar to graph 601 and graph 602represents the recorded data when all of the segmented electrodes ofband 2 are active. Graph 603 represents the recorded data for theindividual segmented electrodes of band 2. For example, point 631represents the identified amplitude for a complete benefit for segmentedelectrode A of band 2 and point 632 represents the identified amplitudefor a sustained side effect for the same segmented electrode. The datapoints for each segmented electrode in graph 603 are connected by linesfor clarity of the graph although any suitable graphical representationmay be alternatively employed.

The amplitudes between the complete benefit amplitude and the sustainedside effect amplitude represents the therapeutic window for a givenelectrode or electrode combination. In the automatically generatedgraphical representations of the monopolar data, the size of therapeuticwindows are readily recognized by the clinician to aid the cliniciansselection of an optimal DBS program.

FIG. 7 depicts report 700 that includes graphical components for acomparison view of the monopolar review data. The data points for thevarious electrodes and electrode combinations are displayed ascorresponding graphs 701-705 for this example data set. Each graph701-705 includes the identified amplitudes for a complete benefit andsustained side effect. The therapeutic window between these values isdisplayed. Also, data metric values are displayed for each applicableelectrode or electrode combination. The window metric is a numericalsize of the therapeutic window—the difference (in milliamperes in someembodiments) between the side effect amplitude value and the benefitamplitude value. The window percentage (window %) is the percentage theamplitude may be increased above the benefit threshold beforeencountering side effects. An equivalent therapeutic window ratio (TWR)metric value (calculated by the window size divided by the recordedbenefit amplitude) could be displayed. Higher values for window size aregenerally preferred for selection of an optimal DBS program. The powermetric represents the power required to deliver therapy at the therapysettings. Lower power consumption is generally preferred for selectionof an optimal DBS program. The data of report 700 may also be filteredaccording to some embodiments. For example, electrodes withinsufficiently sized therapeutic windows may be excluded and/or withoverly taxing power requirements may be excluded.

The display of the monopolar review data in comparison report 700 may besorted to assist the clinician's selection of an optimal DBS program.For example, the data may be sorted by the therapeutic window ratio (orpercentage) metric.

In some embodiments, programmer device 250 automatically defines one ormore progressions through electrodes and electrode combinations fortesting. The progression may be displayed in navigation GUI component301 of UI screen 300. When the clinician completes testing of a givenelectrode, programmer device 250 automatically transitions to the nextelectrode or electrode combination defined by the respective progression(in response to the clinician selecting button 312 of progressionnavigation GUI component 301).

Programmer device 250 may define multiple electrode progressions thatdepend on one or more factors. For example, programmer device 250 mayprompt the clinician upon beginning a screening session whether a“detailed” screening or a “quick” screening is appropriate for a givenpatient. Depending upon the input from the clinician, differentelectrode progressions for the workflow may be selected by the softwareof programmer device 250 for the review session.

In other embodiments, programmer device 250 may prompt the clinician toidentify an electrode or electrode level that is a more likely candidatefor the final DBS program(s). The clinician may make this evaluation ofthe likelihood based upon MER (microelectrode recording data) or anyother suitable clinical data related to the implantation location of theelectrodes of the lead. Depending upon the identification of such anelectrode from the clinician, the electrode progression may differ. Inother embodiments, the clinical data (MER data, imaging data, etc.) maybe provided directly to device 250 and device 250 will select theinitial electrode for the electrode progression for the sessionworkflow.

Also, programmer device 250 may employ multiple progressions in series.The clinician may proceed through multiple progressions for a singlescreening session. During an individual session, the next progressionmay be chosen as a function of data recorded during the priorprogression. For example, if a first set of segmented electrodes testedtogether (for example, 2ABC) produced a therapeutic window of greatersize than a second set of segmented electrodes (3ABC), the nextprogression may start with testing of the individual segmentedelectrodes of the first set (2A, 2B, 2C) rather than the second set (3A,3B, 3C).

In some embodiments, programmer device 250 applies one or moreevaluations of patient response data to determine whether sessiontesting may be terminated without completing a review of the remainingelectrodes. For example, the clinician may define a threshold or targetvalue. The value may be a value for the TWR value that the clinicianbelieves is sufficient to ensure that the patient will experience aneffective DBS therapy. If programmer 250 determines that one or morepreviously tested electrodes or electrode combinations exceed thethreshold or otherwise meet appropriate criteria, programmer device 250may notify the clinician and prompt the clinician to determine how theclinician wishes to proceed. The prompt allows the clinician tointerrupt the electrode progression and immediately view session resultsor to continue with a detailed screening.

FIGS. 8-15 depict respective flows of operations of programmer device250 to guide the clinician through electrode screening. The operationsshown in these FIGS. may be implemented using suitable software code orinstructions stored in memory of programmer device 250. The softwarecode may be included within one or more apps defined for the monopolarreview or other implantable stimulation system programming software ofdevice 250.

FIG. 12 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments. In 1201-1204, the software of device250 automatically guides the clinician through testing of contacts 1,2ABC, 3ABC, and contact 4. For “2ABC” and “3ABC”, all of the segmentedelectrodes on the given level are set as active electrodes for deliveryof the deep brain stimulation. For each tested electrode, the cliniciancontrols the deep brain stimulation (gradually increasing the pulseamplitude) and observes or otherwise monitors the patient response. Theclinician identifies the therapeutic window for each testedelectrode/electrode combination by identifying amplitude values forbenefit(s) and side effect(s).

At 1205, the software of device 250 completes a logical comparison todetermine whether the TWR value is greater for level 2 (2ABC) or forlevel 3 (3ABC) based on the session data. If TWR value for level 2 isgreater, the segmented electrodes for level 2 are tested individually(only one segmented electrode active at a time) at 1206. Otherwise, theprocess flow proceeds from 1205 to 1209.

At 1207, after the individual segmented electrodes of level 2 weretested, a logical comparison is made to determine whether the TWR forone or more of tested electrodes/combinations is greater than a definedthreshold value. If so, the clinician is prompted whether the clinicianwishes to continue with more detailed screening or whether to endscreening to view the results of the review to this point. If theclinician selects to end, the process flow proceeds to 1212 where thesession results are provided to the clinician. For example, reportscreens 600 and 700 may be displayed to the clinician. If not, theprocess flow proceeds from 1207 to 1208 where the segmented electrodesfor level 3 are tested individually (only one segmented electrode activeat a time).

At 1209, the segmented electrodes for level 3 are tested individually(only one segmented electrode active at a time).

At 1210, after the individual segmented electrodes of level 3 weretested, a logical comparison is made to determine whether the TWR forone or more of tested electrodes/combinations is greater than a definedthreshold value. If so, the clinician is prompted whether the clinicianwishes to continue with more detailed screening or whether to endscreening to view the results of the review to this point. If theclinician selects to end, the process flow proceeds to 1212 where thesession results are provided to the clinician. If not, the process flowproceeds from 1210 to 1211 where the segmented electrodes for level 2are tested individually (only one segmented electrode active at a time).

From 1208 and 1211, the process flow proceeds to 1212 where theclinician views session results. In certain other embodiments,additional testing of two segmented electrodes may occur as discussedherein.

FIGS. 8-11 depict respective process flows for session workflows thatvary depending upon an initial identification of a more probableelectrode (either by the physician or by logic of device 250). Asdiscussed herein, the clinician may identify an electrode or electrodelevel to begin the session testing based on MER data, imaging data,and/or other relevant clinical data. Each of FIGS. 8-11 begins with adifferent electrode selection to begin the workflow. The operationsdiscussed in FIGS. 8-11 may be implemented by software operations inclinician programmer device 250 to automatically guide the clinicianthrough a workflow of testing operations.

FIG. 8 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments.

In 801, contact 1 is tested to determine the therapeutic window asdiscussed herein. In 802, a logical comparison is made to determinewhether the TWR value for the tested electrode is greater than a definedthreshold value. If so, the clinician is prompted whether the clinicianwishes to continue with more detailed screening or whether to endscreening to view the results of the review to this point. If theclinician selects to end, the process flow proceeds to 809 where thesession results are provided to the clinician.

In 803, level 2 is tested such that all segmented electrodes on level 2are set to the active state. The testing determines the therapeuticwindow. In 804, a logical comparison is made to determine whether theTWR value is greater than a defined threshold value and whether theclinician wishes to end and immediately view the results. If so, theprocess flow proceeds to 809 where the session results are provided tothe clinician.

In 805, each segmented electrode of level 2 is tested with only onesegmented electrode set as active at a time. The testing determines thetherapeutic window for each segmented electrode. In 806, a logicalcomparison is made to determine whether the TWR value for any of thesegmented electrodes is greater than a defined threshold value andwhether the clinician wishes to end and immediately view the results. Ifso, the process flow proceeds to 809 where the session results areprovided to the clinician.

In 807, level 3 is tested such that all segmented electrodes on level 3are set to the active state. In 808, each segmented electrode of level 3is tested with only one segmented electrode set as active at a time. At809, the session results are provided to the clinician.

FIG. 9 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments. FIG. 9 may be performed when level 2 isidentified or selected as the appropriate electrode to begin a reviewsession of a stimulation lead for a patient.

At 901, level 2 is tested such that all segmented electrodes on level 2are set to the active state. The testing determines the therapeuticwindow. At 902, a logical comparison is made to determine whether theTWR value is greater than a defined threshold value and whether theclinician wishes to end and immediately view the results. If so, theprocess flow proceeds to 916 where the session results are provided tothe clinician.

At 903, level 3 is tested such that all segmented electrodes on level 2are set to the active state. The testing determines the therapeuticwindow. At 904, a logical comparison is made to determine whether theTWR value is greater than a defined threshold value and whether theclinician wishes to end and immediately view the results. If so, theprocess flow proceeds to 916 where the session results are provided tothe clinician.

At 905, a logical comparison is made to determine whether the TWR valuefor level 2 is greater than the TWR value for level 3. If so, theprocess flow proceed to 906. If not, the process flow proceeds to 911.

At 906, each segmented electrode of level 2 is tested with only onesegmented electrode set as active at a time. The testing determines thetherapeutic window for each segmented electrode. In 907, a logicalcomparison is made to determine whether the TWR value for any of thesegmented electrodes is greater than a defined threshold value andwhether the clinician wishes to end and immediately view the results. Ifso, the process flow proceeds to 916 where the session results areprovided to the clinician.

In 908, contact 1 is tested to determine the therapeutic window asdiscussed herein. In 909, a logical comparison is made to determinewhether the TWR value is greater than a defined threshold value andwhether the clinician wishes to end and immediately view the results. Ifso, the process flow proceeds to 916 where the session results areprovided to the clinician.

In 910, each segmented electrode of level 3 is tested with only onesegmented electrode set as active at a time. The process flow proceedsfrom 910 to 916 where the session results are provided to the clinician.

At 911, each segmented electrode of level 3 is tested with only onesegmented electrode set as active at a time. The testing determines thetherapeutic window for each segmented electrode. In 912, a logicalcomparison is made to determine whether the TWR value for any of thesegmented electrodes is greater than a defined threshold value andwhether the clinician wishes to end and immediately view the results. Ifso, the process flow proceeds to 916 where the session results areprovided to the clinician.

In 913, contact 1 is tested to determine the therapeutic window asdiscussed herein. In 914, a logical comparison is made to determinewhether the TWR value is greater than a defined threshold value andwhether the clinician wishes to end and immediately view the results. Ifso, the process flow proceeds to 916 where the session results areprovided to the clinician.

In 915, each segmented electrode of level 2 is tested with only onesegmented electrode set as active at a time. The process flow proceedsfrom 915 to 916 where the session results are provided to the clinician.

FIG. 10 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments. FIG. 10 may be performed when level 3is identified or selected as the appropriate electrode to begin a reviewsession of a stimulation lead for a patient. The process flow in FIG. 10of 1001-1016 is similar to the process flow of FIG. 9 except that theprocess flow of FIG. 10 begins with testing of all of the segmentedelectrodes of level 3 and the all of the segmented electrodes of level2. If electrode 3 is identified as the best starting candidate,electrode 4 is more likely to be an optimal selection (after electrode3). Accordingly, in FIG. 10, electrode 4 is screened and electrode 1 isomitted. The process flow is essentially the same upon bifurcation ofthe workflow upon the comparison of the TWR values for level 3 and level2 at 1005 with the exception that contact 4 is screened.

FIG. 11 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments. FIG. 11 may be performed when contact 4is identified or selected as the appropriate electrode to begin a reviewsession of a stimulation lead for a patient.

In 1101, contact 4 is tested to determine the therapeutic window asdiscussed herein. In 1102, a logical comparison is made to determinewhether the TWR value for the tested electrode is greater than a definedthreshold value. If so, the clinician is prompted whether the clinicianwishes to continue with more detailed screening or whether to endscreening to view the results of the review to this point. If theclinician selects to end, the process flow proceeds to 1109 where thesession results are provided to the clinician.

In 1103, level 3 is tested such that all segmented electrodes on level 3are set to the active state. The testing determines the therapeuticwindow. In 1104, a logical comparison is made to determine whether theTWR value is greater than a defined threshold value and whether theclinician wishes to end and immediately view the results. If so, theprocess flow proceeds to 1109 where the session results are provided tothe clinician.

In 1105, each segmented electrode of level 3 is tested with only onesegmented electrode set as active at a time. The testing determines thetherapeutic window for each segmented electrode. In 1106, a logicalcomparison is made to determine whether the TWR value for any of thesegmented electrodes is greater than a defined threshold value andwhether the clinician wishes to end and immediately view the results. Ifso, the process flow proceeds to 1109 where the session results areprovided to the clinician.

In 1107, level 2 is tested such that all segmented electrodes on level 3are set to the active state. In 1108, each segmented electrode of level2 is tested with only one segmented electrode set as active at a time.At 1109, the session results are provided to the clinician.

FIG. 13 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments. The process flow of FIG. 13 permitsadditional testing of segmented electrodes if believed appropriate by aclinician. The configuration for screening in FIG. 13 uses aconfiguration of only two segmented electrodes. The clinician may accessthis testing option via progression navigation GUI component 301according to some embodiments.

In 1301, a therapeutic window metric (e.g., the TWR metric) iscalculated for the segmented electrodes of the DBS lead. The segmentedelectrodes with the highest metric values are identified (denoted byTWR1 for the highest value and TWR2 for the second highest value). In1302, a logical comparison is made based on the TWR1 and TWR2 values. Ifthe value of 1−(TWR1−TWR2) is less than 0.8 or another suitable value,the process flow proceeds from 1302 to 1304 where the screening resultsare displayed. If the value of 1−(TWR1−TWR2) is greater than or equal to0.8 or another suitable value, the process flow proceeds from 1302 to1303. In 1303, the two segmented electrodes exhibiting these values areset as active electrodes and subjected to screening to determine thetherapeutic window for these electrodes. In 1304, the screening resultsare provided to the clinician including the results of the screening ofthe segmented electrodes for the TWR1 and TWR2 values (both of thesesegmented electrodes simultaneously set as the active electrodes).

FIG. 14 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments.

In 1401, clinician programmer 250 prompts the clinician user whether theuser wishes to conduct a full screening review or an abbreviatedscreening review. In response the received user input, a logicalcomparison is made in 1402. If the user indicated abbreviated screening,the process flow proceeds to 1403. An abbreviated screening review maybe performed in which screening one or more electrodes may be omitted.The omission of screening of certain electrodes may depend upon patientresponse data that is received. The electrode progressions and the logicfor proceeding to electrodes and omitting screening of electrodes may beperformed according to any suitable manner including the work flowsdescribed herein. If the user wishes to conduct a full screening, theprocess flow proceeds from 1402 to 1404 where a suitable screeningreview occurs.

FIG. 15 depicts a flow of operations for conducting a review ofelectrodes of a DBS lead that includes segmented electrodes according tosome representative embodiments. In 1501, user input or clinical data isreceived by programmer device 250. In 1502, the initial electrode isselected based on the input or the received clinical data. The userinput may directly identify an appropriate electrode or electrode levelto begin a screening session. Alternatively, clinical data may bereceived. For example, MER recording data and/or imaging data may bereceived which may be process to identify an appropriate electrode orelectrode level. For example, Lozano discloses identifying locationswithin the brain for targeting for DBS based on analysis of MER data inU.S. Patent App. Pub. No. 201000204748 entitled “Identifying areas ofthe brain by examining the neuronal signals,” which is incorporatedherein by reference. Analysis of MER data at respective locationsagainst appropriate signal characteristics (spiking rates, frequencycontent, boundary conditions) from an implant procedure and comparisonto electrode locations may be employed to select the electrode orelectrode level for screening. In 1503, an electrode progression isselected based on the selected electrode or electrode level. In 1504,electrode screening operations begin based on the selected electrodeprogression.

FIG. 16 illustrates an example computer system 1600 that may beconfigured to include or execute any or all of the embodiments describedabove. In different embodiments, computer system 1600 may be any ofvarious types of devices, including, but not limited to, a personalcomputer system, desktop computer, laptop, notebook, tablet, slate, pad,or netbook computer, cell phone, smartphone, PDA, portable media device,handheld computer, or a mobile device.

Various embodiments of a clinician programmer for a deep brainstimulation system, as described herein, may be executed in one or morecomputer systems 1600, which may interact with various other devices. Insome embodiments, computer system 1600 includes one or more processors1610 coupled to a system memory 1620 via an input/output (I/O) interface1630. Computer system 1600 further includes a network interface 1640coupled to I/O interface 1630, and one or more input/output devices1650, such as cursor control device 1660, keyboard 1670, and display(s)1680.

In various embodiments, computer system 1600 may be a uniprocessorsystem including one processor 1610, or a multiprocessor systemincluding several processors 1610 (e.g., two, four, eight, or anothersuitable number). Processors 1610 may be any suitable processor capableof executing instructions. For example, in various embodimentsprocessors 1610 may be general-purpose or embedded processorsimplementing any of a variety of instruction set architectures (ISAs),such as the x86, PowerPC, SPARC, or MIPS ISAs, or any other suitableISA. In multiprocessor systems, each of processors 1610 may commonly,but not necessarily, implement the same ISA.

System memory 1620 may be configured to store clinician programmingsoftware instructions or code 1622 accessible by processor 1610. Invarious embodiments, system memory 1620 may be implemented using anysuitable memory technology, such as static random access memory (SRAM),synchronous dynamic RAM (SDRAM), nonvolatile/Flash-type memory, or anyother type of memory. In some embodiments, software instructions 1622may be configured to implement one or more of the work flows describedherein and/or provide one or more of the user interface screensdescribed herein. Additionally, program instructions 1622 of memory 1620may include any of the information or data structures described above.In some embodiments, program instructions and/or data may be received,sent or stored upon different types of computer-accessible media or onsimilar media separate from system memory 1620 or computer system 1600.While computer system 1600 is described as implementing thefunctionality of functional blocks of previous Figures, any of thefunctionality described herein may be implemented via such a computersystem.

In one embodiment, I/O interface 1630 may be configured to coordinateI/O traffic between processor 1610, system memory 1620, and anyperipheral devices in the device, including network interface 1640 orother peripheral interfaces, such as input/output devices 1650. In someembodiments, I/O interface 1630 may perform any necessary protocol,timing or other data transformations to convert data signals from onecomponent (e.g., system memory 1620) into a format suitable for use byanother component (e.g., processor 1610). In some embodiments, I/Ointerface 1630 may include support for devices attached through varioustypes of peripheral buses, such as a variant of the Peripheral ComponentInterconnect (PCI) bus standard or the Universal Serial Bus (USB)standard, for example. In some embodiments, the function of I/Ointerface 1630 may be split into two or more separate components, suchas a north bridge and a south bridge, for example. Also, in someembodiments some or all of the functionality of I/O interface 1630, suchas an interface to system memory 1620, may be incorporated directly intoprocessor 1610.

Network interface 1640 may be configured to allow data to be exchangedbetween computer system 1600 and other devices attached to a network1685 (e.g., carrier or agent devices) or between nodes of computersystem 1600. Network 1685 may in various embodiments include one or morenetworks including but not limited to Local Area Networks (LANs) (e.g.,an Ethernet or corporate network), Wide Area Networks (WANs) (e.g., theInternet), wireless data networks, some other electronic data network,or some combination thereof. In various embodiments, network interface1640 may support communication via wired or wireless general datanetworks.

Input/output devices 1650 may, in some embodiments, include one or moredisplay terminals, keyboards, keypads, touchpads, scanning devices,voice or optical recognition devices, or any other devices suitable forentering or accessing data by one or more computer systems 1600.Multiple input/output devices 1650 may be present in computer system1600 or may be distributed on various nodes of computer system 1600. Insome embodiments, similar input/output devices may be separate fromcomputer system 1600 and may interact with one or more nodes of computersystem 1600 through a wired or wireless connection, such as over networkinterface 1640.

As shown in FIG. 16, memory 1620 may include software instructions 1622,which may be processor-executable to implement any element or actiondescribed above. In some embodiments, the software instructions mayimplement deep brain stimulation programming and electrode screeningoperations described herein.

Those skilled in the art will appreciate that computer system 1600 ismerely illustrative and is not intended to limit the scope ofembodiments. In particular, the computer system and devices may includeany combination of hardware or software that can perform the indicatedfunctions or operations. Computer system 1600 may also be connected toother devices that are not illustrated, or instead may operate as astand-alone system. In addition, the functionality provided by theillustrated components may in some embodiments be combined in fewercomponents or distributed in additional components. Similarly, in someembodiments, the functionality of some of the illustrated components maynot be provided and/or other additional functionality may be available.

Those skilled in the art will also appreciate that, while various itemsare illustrated as being stored in memory or on storage while beingused, these items or portions of them may be transferred between memoryand other storage devices for purposes of memory management and dataintegrity. Alternatively, in other embodiments some or all of thesoftware components may execute in memory on another device andcommunicate with the illustrated computer system via inter-computercommunication. Some or all of the system components or data structuresmay also be stored (e.g., as instructions or structured data) on acomputer-accessible medium or a portable article to be read by anappropriate drive, various examples of which are described above.Generally speaking, a computer-accessible medium may include anon-transitory, computer-readable storage medium or memory medium suchas magnetic or optical media, e.g., disk or DVD/CD-ROM, volatile ornon-volatile media such as RAM (e.g. SDRAM, DDR, RDRAM, SRAM, etc.),ROM, etc.

FIG. 17 depicts a flowchart for treating a neurological disorder of apatient using an implantable pulse generator and a lead with segmentedelectrodes according to some embodiments. In 1701, a clinician conductsan electrode screening review with an appropriate programmer deviceaccording to one or more of the embodiments discussed herein. In 1702,the clinician analyzes the therapeutic windows for electrode andelectrode combinations from the screening review. In 1703, the cliniciandefines a DBS program for the patient based on the screening data. Forexample, the clinician may select an electrode or electrode combinationwith a suitably large therapeutic window. Also, the clinician may selectbetween suitable electrodes and electrode combinations by consideringthe power requirements. In 1704, the clinician communicates the DBSprogram to the patient's IPG. In 1705, the patient's therapy is startedby delivering electrical stimulation from the IPG to the patient usingone or more directional leads.

Although certain embodiments of this disclosure have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this disclosure. All directionalreferences (e.g., upper, lower, upward, downward, left, right, leftward,rightward, top, bottom, above, below, vertical, horizontal, clockwise,and counterclockwise) are only used for identification purposes to aidthe reader's understanding of the present disclosure, and do not createlimitations, particularly as to the position, orientation, or use of thedisclosure. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not limiting. Changes in detail or structure may be made withoutdeparting from the spirit of the disclosure as defined in the appendedclaims.

When introducing elements of the present disclosure or the preferredembodiment(s) thereof, the articles “a”, “an”, “the”, and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including”, and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As various changes could be made in the above constructions withoutdeparting from the scope of the disclosure, it is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

1. A clinician programmer device for controlling a deep brainstimulation (DBS) system, the clinician programmer device comprising: adisplay; user input circuitry for receiving input from a user of thedevice; memory for storing executable instructions and data; a processorfor controlling operations of the clinician programmer according toexecutable instructions; and wireless communication circuitry forconducting wireless communications with an implantable pulse generatorafter implantation within a patient; wherein (1) the memory storessoftware code for conducting a screening review of electrodes of animplantable stimulation lead coupled to the implantable pulse generator,(2) the electrodes of the implantable stimulation lead include at leastone set of segmented electrodes, and (3) the software code comprises:(a) code for providing one or more interface screens for guiding theuser of the device through testing of electrode configurations of theimplantable stimulation lead, wherein the code for providing applies atleast one testing progression for guiding the user of the device througha defined testing order, wherein the at least one testing progressionincludes (i) testing all segmented electrodes of a common level asactive DBS electrodes and (ii) testing each segmented electrode of thecommon level as a single active DBS electrode; (b) code for controllingdelivery of deep brain stimulation to the patient by communication withthe implantable pulse generator for each tested electrode configuration,wherein the code for controlling modifies a DBS pulse amplitude for eachtested electrode configuration; and (c) code for receivingidentification of a therapeutic window for one or more DBS parametersfor each tested electrode configuration, wherein the therapeutic windowis defined by one or more DBS parameters used for test stimulation for aDBS benefit and a DBS side effect experienced by the patient duringtesting.
 2. The device of claim 1 wherein the code for receivingidentification records a side effect amplitude value in responsereceiving input from the user of the device to indicate that the patienthas experienced a side effect and the code for controlling automaticallydecreases the DBS pulse amplitude to an amplitude value below therecorded amplitude value.
 3. The device of claim 2 wherein the code forcontrolling automatically decreases the DBS pulse amplitude withoutsubstantially interrupting deep brain stimulation of the patientaccording to an electrode configuration under test.
 4. The device ofclaim 1 wherein the software code further comprises: code for comparingtherapeutic windows for each tested electrode configuration to a targetvalue and code for alerting a user of the device that the target valuehas been reached.
 5. The device of claim 4 wherein the code for alertingreceives input from the user of the device whether to skip additionalelectrode screening after the target value has been reached.
 6. Thedevice of claim 1 wherein the software code further comprising: code forcomparing power requirements associated with the therapy thresholds forthe tested electrode configuration to inform the user of the devicewhether each electrode configuration is likely to provide an optimal DBSprogram for the patient.
 7. The device of claim 1 wherein the softwarecode further comprises: code for suggesting omission of testing of oneor more electrode configurations based on screening review datapreviously recorded for the patient by the code of receivingidentification.
 8. The device of claim 1 wherein the software codefurther comprises: code for displaying one or more graphical userinterface components depicting respective therapeutic window data fortested electrode configurations.
 9. A method of programming animplantable pulse generator to provide a deep brain stimulation therapyto a patient using one or more electrodes of a directional lead, themethod comprising: providing one or more interface screens, by aclinician programmer device, for guiding a user of the clinicianprogrammer device through testing of electrode configurations of theimplantable stimulation lead, wherein the providing one or moreinterface screens applies at least one testing progression for guidingthe user of the clinician programmer device through a defined testingorder, wherein the at least one testing progression includes (i) testingall segmented electrodes of a common level of the directional lead asactive DBS electrodes and (ii) testing each segmented electrode of thecommon level of the directional lead as a single active DBS electrode;controlling delivery of deep brain stimulation to the patient using theclinician programmer device by communication with an implantable pulsegenerator for each tested electrode configuration, wherein thecontrolling modifies a DBS pulse amplitude for each tested electrodeconfiguration; and receiving identification of a therapeutic window bythe clinician programmer device for one or more DBS parameters for eachtested electrode configuration, wherein the therapeutic window isdefined by one or more DBS parameters used for test stimulation for aDBS benefit and a DBS side effect experienced by the patient duringtesting; defining a deep brain stimulation program using one or moreelectrodes of the stimulation lead with a respective therapeutic windowidentified by the receiving identification; and communicating the deepbrain stimulation program to the implantable pulse generator fortherapeutic operations of the implantable pulse generator.
 10. Themethod of claim 9 wherein the receiving identification records a sideeffect amplitude value in response receiving input from the user of theclinician programmer device to indicate that the patient has experienceda side effect and the code for controlling automatically decreases theDBS pulse amplitude to an amplitude value below the recorded amplitudevalue.
 11. The method of claim 10 wherein the controlling automaticallydecreases the DBS pulse amplitude without substantially interruptingdeep brain stimulation of the patient according to an electrodeconfiguration under test.
 12. The method of claim 9 further comprising:comparing therapeutic windows for each tested electrode configuration toa target value and alerting a user of the device that the target valuehas been reached, wherein the comparing and alerting are performed bythe clinician programmer device.
 13. The method of claim 12 furthercomprising: receiving input from the user of the clinician programmerdevice whether to skip additional electrode screening after the targetvalue has been reached.
 14. The method of claim 9 further comprising:comparing power requirements associated with the therapy thresholds forthe tested electrode configuration by the clinician programmer deviceand informing the user of the clinician programmer device whether eachelectrode configuration is likely to provide an optimal DBS program forthe patient.
 15. The method of claim 9 further comprising: providing asuggestion message, by the clinician programmer device, to omit oftesting of one or more electrode configurations based on screeningreview data previously recorded for the patient.